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Brief Title: Safety and Efficacy of ATIR101 as Adjunctive Treatment to Blood Stem Cell Transplantation From a Haploidentical Family Donor Compared to Post-transplant Cyclophosphamide in Patients With Blood Cancer
Official Title: A Phase III, Multicenter, Randomized Controlled Study to Compare Safety and Efficacy of a Haploidentical HSCT and Adjunctive Treatment With ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted ex Vivo of Host Alloreactive T-cells, Versus a Haploidentical HSCT With Post-transplant Cyclophosphamide in Patients With a Hematologic Malignancy
Study ID: NCT02999854
Brief Summary: The primary objective of this study is to compare safety and efficacy of a haploidentical T-cell depleted HSCT and adjunctive treatment with ATIR101 versus a haploidentical T cell replete HSCT with post-transplant administration of high dose cyclophosphamide (PTCy) in patients with a hematologic malignancy. An additional objective of the study is to compare the effect of the two treatments on quality of life.
Detailed Description: Study CR-AIR-009 is a Phase III randomized controlled multicenter open-label study comparing two parallel groups. After signing informed consent, a total of 250 patients will be randomized in a 1:1 fashion to receive either a T-cell depleted hematopoietic stem cell transplantation (HSCT; CD34 selection) from a related, haploidentical donor, followed by ATIR101 infusion, or a T-cell replete HSCT, followed by a high dose of post-transplant cyclophosphamide (PTCy). Randomization will use minimization to balance treatment groups with respect to underlying disease (AML, ALL, or MDS), Disease Risk Index (DRI; intermediate risk, high risk, or very high risk) and center. A stochastic treatment allocation procedure will be used so that the treatment assignment is random for all patients entered in the study. Patients randomized in the ATIR101 group will receive a single ATIR101 dose of 2×10E6 viable T-cells/kg between 28 and 32 days after the HSCT. Patients randomized in the PTCy group will receive cyclophosphamide 50 mg/kg/day at 3 and 4/5 days after the HSCT. All patients will be followed up for at least 24 months post HSCT.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope National Medical Center, Duarte, California, United States
Moores UC San Diego Cancer Center, La Jolla, California, United States
UCLA Center for Health Sciences, Los Angeles, California, United States
Stanford University School of Medicine, Stanford, California, United States
Emory University, Atlanta, Georgia, United States
University of Kansas Cancer Center, Westwood, Kansas, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Weill Cornell Medical College, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
Stony Brook University Hospital, Stony Brook, New York, United States
Oregon Health & Science University, Portland, Oregon, United States
Universitair Ziekenhuis Antwerpen, Antwerp, , Belgium
Algemeen Ziekenhuis Sint-Jan, Brugge, , Belgium
Institut Jules Bordet, Brussels, , Belgium
Universitair Ziekenhuis Gasthuisberg, Leuven, , Belgium
Centre Hospitalier Universitaire de Liège, Liège, , Belgium
Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada
University Hospital Centre Zagreb, Zagreb, , Croatia
APHP Hospital Saint Louis, Paris, , France
University Hospital Frankfurt, Goethe University, Frankfurt, , Germany
University Medical Center Mainz, Mainz, , Germany
Ludwig-Maximilians-University Hospital of Munich-Grosshadern, Munich, , Germany
Universitätsklinikum Würzburg, Würzburg, , Germany
Rambam Medical Center, Haifa, , Israel
Hadassah Medical Center & Hadassah Hospital Ein Karem, Jerusalem, , Israel
Sourasky Medical Center & Tel Aviv University, Tel Aviv, , Israel
Chaim Sheba Medical Center, Tel-Hashomer, , Israel
Milano Hospital, Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milano, , Italy
Fondazione IRCCS Policlinico San Matteo, Pavia, , Italy
Academisch Ziekenhuis Maastricht, Maastricht, , Netherlands
Faculdade de Medicina da Universidade de Lisboa, Lisboa, , Portugal
University Hospital Barcelona Vall d' Hebron, Barcelona, , Spain
Hospital Puerta de Hierro Majadahonda, Madrid, , Spain
UGC Hematología y Hemoterapia, Sevilla, , Spain
Servicio de Hematología Hospital, Universitari I politècnic La Fe, Valencia, , Spain
Karolinska University Hospital, Stockholm, , Sweden
Heartlands Hospital, Birmingham, , United Kingdom
St James University Hospital, Leeds, , United Kingdom
Royal Liverpool University Hospital, Liverpool, , United Kingdom
Hammersmith Hospital, London, , United Kingdom
Manchester Royal Infirmary, Manchester, , United Kingdom
Name: Denis Claude Roy, Prof MD
Affiliation: Research Center and Cellular Therapy Laboratory, Maisonneuve-Rosemont Hospital (Montreal, Canada)
Role: PRINCIPAL_INVESTIGATOR
Name: Stephan Mielke, Prof MD
Affiliation: Centre for Allogeneic Stem Cell Transplantation, Karolinska University Hospital (Stockholm, Sweden)
Role: PRINCIPAL_INVESTIGATOR